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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04607837




Registration number
NCT04607837
Ethics application status
Date submitted
23/10/2020
Date registered
29/10/2020

Titles & IDs
Public title
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
Scientific title
A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
Secondary ID [1] 0 0
C5041011
Secondary ID [2] 0 0
APD334-210
Universal Trial Number (UTN)
Trial acronym
GLADIATOR UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo

Experimental: Etrasimod 2 mg -

Placebo comparator: Placebo -


Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment

Treatment: Drugs: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Achieving Clinical Remission
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of Participants Achieving Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of Participants Achieving Endoscopic Improvement
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Proportion of Participants Achieving Symptomatic Remission
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Proportion of Participants Achieving Mucosal Healing
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Proportion of participants achieving clinical remission at both Weeks 12 and 52
Timepoint [5] 0 0
Week 12 and Week 52
Secondary outcome [6] 0 0
Proportion of Participants achieving clinical remission at Week 52 and who had not been receiving corticosteroids for = 12 weeks immediately prior to Week 52
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Number and Severity of Adverse Events
Timepoint [7] 0 0
Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period)

Eligibility
Key inclusion criteria
* Diagnosed with Ulcerative Colitis (UC) = 3 months prior to screening
* Active UC confirmed by endoscopy
* Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score = 2 and rectal bleeding score = 1
* Received a surveillance colonoscopy within 12 months before baseline
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe extensive colitis
* Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
* Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/06/2024
Sample size
Target
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Sydney
Recruitment hospital [2] 0 0
Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility ) - Birtinya
Recruitment hospital [3] 0 0
Sunshine Coast Radiology - Birtinya
Recruitment hospital [4] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [5] 0 0
Buderim Eye Centre( OCT and Ophthalmoscopy Facility) - Buderim
Recruitment hospital [6] 0 0
Coral Sea Clinical Research Institute Pty.Ltd - Mackay
Recruitment hospital [7] 0 0
Coastal Digestive Helath Pty. Ltd - Maroochydore
Recruitment hospital [8] 0 0
Dr.Shiran DeSilva Respiratory Clinic (PFT) - North Mackay
Recruitment hospital [9] 0 0
Mater Misericordiae Hospital ( Endoscopy) - North Mackay
Recruitment hospital [10] 0 0
Queensland X-Ray - North Mackay
Recruitment hospital [11] 0 0
Vision Eye Institute Mackay (OCT) - North Mackay
Recruitment hospital [12] 0 0
Austin Health - Heidelberg
Recruitment hospital [13] 0 0
Melbourne Health - Parkville
Recruitment postcode(s) [1] 0 0
2200 - Sydney
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4575 - Buderim
Recruitment postcode(s) [4] 0 0
4740 - Mackay
Recruitment postcode(s) [5] 0 0
4558 - Maroochydore
Recruitment postcode(s) [6] 0 0
4740 - North Mackay
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Maryland
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Massachusetts
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Missouri
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New Hampshire
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Ohio
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Pennsylvania
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Belarus
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Gomel
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Grodno
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Vitebsk
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Gent
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Roeselare
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Ruse
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Sliven
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Sofia
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Veliko Tarnovo
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Alberta
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Canada
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Ontario
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Quebec
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Boskovice
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Hradec Kralove
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Olomouc
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Ostrava-Poruba
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Czechia
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Praha 7
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Czechia
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Prerov
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Slany
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Rennes Cedex 09
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Tbilisi
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Remscheid
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Heves
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Rehovot
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Portugal
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Porto
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Russian Federation
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Stavropol Region
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Omsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Stavropol
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Spain
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Alicante
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Spain
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Madrid
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Ukraine
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Dnipro
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Uzhgorod
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Ukraine
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Vinnytsia
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Ukraine
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Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04607837